Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125264982 | 12526498 | 2 | F | 201606 | 20160803 | 20160705 | 20160809 | EXP | PHHY2016BR089863 | NOVARTIS | 54.87 | YR | M | Y | 85.00000 | KG | 20160809 | MD | BR | BR |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125264982 | 12526498 | 1 | PS | RITALIN LA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Oral | 20 MG, QD | Y | 21284 | 20 | MG | EXTENDED RELEASE CAPSULES | QD | |||||
| 125264982 | 12526498 | 2 | C | TEGRETOL CR | CARBAMAZEPINE | 1 | Oral | 2 DF, QD | 0 | 2 | DF | TABLET | QD | ||||||
| 125264982 | 12526498 | 3 | C | DONAREN | TRAZODONE HYDROCHLORIDE | 1 | Oral | 0.66 DF, QD | 0 | .66 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125264982 | 12526498 | 1 | Cataplexy |
| 125264982 | 12526498 | 2 | Product used for unknown indication |
| 125264982 | 12526498 | 3 | Rapid eye movements sleep abnormal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125264982 | 12526498 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125264982 | 12526498 | Cerebrovascular accident | |
| 125264982 | 12526498 | Drug ineffective | |
| 125264982 | 12526498 | Drug intolerance | |
| 125264982 | 12526498 | Malaise | |
| 125264982 | 12526498 | Narcolepsy | |
| 125264982 | 12526498 | Product use issue | |
| 125264982 | 12526498 | Somnolence | |
| 125264982 | 12526498 | Syncope |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125264982 | 12526498 | 1 | 20160616 | 0 |